US12161819B2 - Catheter placement device including an extensible needle safety component - Google Patents

Abstract

An insertion device for inserting a catheter into a patient's body is disclosed. In some embodiments, the insertion device combines needle insertion, guidewire advancement, catheter insertion, and needle shielding in a single device. In one embodiment, the insertion device comprises a housing including a hollow needle distally extending from the housing. At least a portion of the catheter is pre-disposed over the needle such that the catheter is disposed substantially external to the housing. A guidewire is included, as well as an advancement assembly that is configured to selectively advance the distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter. The advancement assembly is further configured to enable distal catheter advancement before shielding the needle after use. The insertion device is configured to be grasped and used by a single hand of a user.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No. 15/154,384, filed May 13, 2016, now U.S. Pat. No. 11,040,176, which claims the benefit of priority to U.S. Provisional Application No. 62/162,548, filed May 15, 2015, each of which is incorporated by reference in its entirety into this application.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed to an insertion device for inserting a catheter or other tubular medical device into a body of a patient. The insertion device combines needle insertion, guidewire advancement, catheter insertion, and needle shielding in a single device. In one embodiment, the insertion device comprises a housing and a hollow needle that distally extends from the housing. At least a portion of the catheter is pre-disposed over the needle such that the catheter is disposed substantially external to the housing. A guidewire is included, as well as an advancement assembly that is configured to selectively advance the distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter. The advancement assembly is further configured to enable selective advancement of the catheter in a distal direction. The insertion device is configured to be grasped and used by a single hand of a user during advancement of the guidewire and the catheter.

In another embodiment, continuous blood flash indicators are disclosed to assist in confirming that the needle of the catheter insertion device has accessed and remains in a vein or other blood-carrying vessel. In yet another embodiment, needle safety components are disclosed for use with the catheter insertion device.

These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the invention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIGS.1A-1J show various views of a catheter insertion tool according to one embodiment;

FIGS.2A-2C show various views of components of the catheter insertion tool ofFIGS.1A-1J;

FIGS.3A-3C show various stages of use of the catheter insertion tool ofFIGS.1A-1J;

FIG.4 is a cross-sectional side view of a blood flash indicator according to one embodiment;

FIG.5 is a perspective view of a blood flash indicator according to one embodiment;

FIG.6 is a top view of a blood flash indicator according to one embodiment;

FIG.7 is a top view of a blood flash indicator according to one embodiment;

FIGS.8A-8H are various views of a catheter insertion tool according to one embodiment;

FIGS.9A-9G are various views of a needle safety component according to one embodiment;

FIG.10 is a cross-sectional view of a needle and guidewire according to one embodiment;

FIG.11 is a cross-sectional view of a needle and guidewire according to one embodiment;

FIG.12 is a cross-sectional view of a needle and guidewire according to one embodiment;

FIG.13 is a partial cross-sectional side view of a needle and guidewire according to one embodiment;

FIG.14 is a partial cross-sectional side view of a needle and guidewire according to one embodiment;

FIG.15 is a partial cross-sectional side view of a needle and guidewire according to one embodiment;

FIG.16 is a partial cross-sectional side view of a needle and guidewire according to one embodiment;

FIG.17 is a side view of a guidewire according to one embodiment;

FIG.18 is a perspective view of an advancement member of a catheter insertion tool according to one embodiment;

FIG.19 is a top view of a blood flash indicator according to one embodiment;

FIG.20 is a top view of a blood flash indicator according to one embodiment;

FIG.21 is a top view of a blood flash indicator according to one embodiment;

FIG.22 is a top view of a blood flash indicator according to one embodiment;

FIG.23 is a top view of a blood flash indicator according to one embodiment;

FIG.24 is a top view of a blood flash indicator according to one embodiment;

FIG.25 is a top view of a blood flash indicator according to one embodiment;

FIGS.26A-26D are various views of a catheter insertion tool according to one embodiment;

FIGS.27A-27E are various views of a catheter insertion tool according to one embodiment;

FIG.28 is a perspective view of a blood flash indicator according to one embodiment;

FIG.29 is a perspective view of a catheter insertion tool according to one embodiment; and

FIGS.30A and30B depict various views of a blood flash indicator according to one embodiment.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither limiting nor necessarily drawn to scale.

For clarity it is to be understood that the word “proximal” refers to a direction relatively closer to a clinician using the device to be described herein, while the word “distal” refers to a direction relatively further from the clinician. For example, the end of a catheter placed within the body of a patient is considered a distal end of the catheter, while the catheter end remaining outside the body is a proximal end of the catheter. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”

Embodiments of the present invention are generally directed to a tool for assisting with the placement into a patient of a catheter or other tubular medical device. For example, catheters of various lengths are typically placed into a body of a patient so as to establish access to the patient's vasculature and enable the infusion of medicaments or aspiration of body fluids. The catheter insertion tool to be described herein facilitates such catheter placement. Note that, while the discussion below focuses on the placement of catheters of a particular type and relatively short length, catheters of a variety of types, sizes, and lengths can be inserted via the present device, including peripheral IVs, intermediate or extended-dwell catheters, PICCs, central venous catheters, etc. In one embodiment, catheters having a length between about 1 inch and about 1.9 inches can be placed, though many other lengths are also possible.

FIGS.1A-1J depict various details regarding a catheter insertion tool (“insertion tool” or “insertion device”), generally depicted at10, according to one embodiment. As shown, theinsertion tool10 includes ahousing12 that may itself include a topfront housing portion12A, a top back housing portion12B, and a bottom housing portion12C mated with one another via tabs andslots78 or other suitable attachment modes. Thehousing12 further includes an opendistal end12D, and aflat bottom12E to enable theinsertion device10 to lie flat on a surface without tipping. In another embodiment, the housing is integrally formed. In yet another embodiment, only a top housing portion and a bottom housing portion are employed. In the present embodiment, the housing composed of a thermoplastic such as polycarbonate and is translucent, though other configurations are contemplated. Arib38 runs along the longitudinal length of the bottom housing portion12C, in the present embodiment. Thehousing12 defines grip surfaces74 on either side of the housing, as seen inFIGS.1B and1G, to enable grasping of theinsertion device10 by the user.

Aneedle hub14 supporting a hollow needle16 (which together form part of a needle assembly, in one embodiment) is included with thehousing12. In the present embodiment, theneedle hub14 is integrally formed with thehousing12 within acavity70 defined by the housing, as best seen inFIG.1I, though the needle hub can be configured in other ways. Theneedle hub14 includes a pocket14A for receiving a portion of theneedle16 and a quantity of adhesive, such as liquid or UV-cure adhesive for example, in order to fix the needle in place in the needle hub. Theneedle16 extends distally from theneedle hub14 so as to extend out an opendistal end12D of thehousing12 and terminates at a distal end16B. Anotch18 is defined through the wall of theneedle16 proximate the distal end thereof. Thenotch18 enables flashback of blood to exit the lumen defined by thehollow needle16 once access to the patient's vasculature is achieved during catheter insertion procedures. Thus, blood exiting thenotch18 can be viewed by a clinician to confirm proper needle placement in the vasculature, as will be explained further below.

Acatheter42 is removably disposed on the portion of theneedle16 residing external to thehousing12 such that the needle occupies a lumen of the catheter defined by acatheter tube44. Thecatheter tube44 extends distally from ahub46 of thecatheter42, which hub is initially disposed adjacent the opendistal end12D of thehousing12, as shown inFIGS.1A-1C.

Theinsertion tool10 further includes aguidewire advancement assembly20 for advancing aguidewire22 through theneedle16 and into the vasculature of the patient once access by the needle has been achieved. The guidewire22 (FIG.1I) is pre-disposed within the lumen of theneedle16. Theguidewire advancement assembly20 includes aguidewire lever24 that selectively advances theguidewire22 in a distal direction during use of theinsertion tool10 such that the distal portion of the guidewire extends beyond the distal end16B of theneedle16. Afinger pad28 of theguidewire lever24 is slidably disposed on thehousing12 via aslot32 to enable a thumb and/or finger(s) of the user to selectively advance theguidewire22 distally past the distal end16B of theneedle16. Of course, other engagement schemes to translate user input to guidewire movement could also be employed. In the present embodiment, theguidewire22 includes a guidewire support tube19 (FIGS.1I,1J) to provide additional stiffness to the guidewire and facilitate its distal advancement described above.

Together withFIG.1H, reference is made toFIGS.2A-2C in describing further details of theinsertion tool10 ofFIGS.1A-1J. Further details of theguidewire lever24 are shown, including alever tab26 at the proximal end of the guidewire lever that is used as described below in distally advancing theguidewire22. Anangled portion24A of theguidewire lever24 is disposed distal to thelever tab26. Apush tab30 is defined below thefinger pad28 and is employed during distal advancement of theguidewire lever24 to partially advance thecatheter42 distally, as will be described below.

In the present embodiment, a proximal end of theguidewire22 is attached at ananchor point36 on an interior portion of the housing12 (or other fixed portion of the insertion tool10) and looped about the proximal portion of theguidewire lever24 in a roughly U-shaped configuration (FIG.1H) such that the distal end of the guidewire extends two units of distance distally past the distal end16B of theneedle16 for every one unit of distance of movement of thefinger pad28.

In greater detail,FIGS.2A-2C show that curved guide surfaces34 are defined on the proximal end of theguidewire lever24 to enable an intermediate portion of theguidewire22 to loop back on itself proximate the proximal end of thedevice10. The guide surfaces34 constrain theflexible guidewire22 into the looped, substantially U-shaped configuration. Theangled portion24A of theguidewire lever24 helps to maintain the radius of the U-shaped portion of theguidewire22 large enough so as to prevent kinking/undesired bending of the guidewire as it loops back. The looped-back intermediate portion of theguidewire22 then extends toward the distal end of thedevice10 within thecavity70 of thehousing12 before it enters the lumen of theneedle16 at a proximal end of the needle, which is secured by theneedle hub14. Abar34A is positioned across the guide surfaces34 in the present embodiment to keep the guidewire22 in contact with the guide surfaces. In one embodiment, therib38 can include a channel in which a portion of the intermediate portion of the loopedguidewire22 can reside so as to guide the guidewire toward the proximal end of theneedle16.

So configured, the free distal end of theguidewire22 initially resides within the lumen of theneedle16 and is positioned for selective advancement by theguidewire advancement assembly20 such that the free distal end thereof can distally extend from the open distal tip of theneedle16. This selective advancement of theguidewire22 is achieved in the present embodiment via distal movement of thefinger pad28 included on thedevice housing12. Distal movement of thefinger pad28 causes corresponding distal sliding movement of theguidewire lever24. The guide surfaces34 of theguidewire lever26 push the bend of theguidewire22 distally as theguidewire lever24 advances. Note that theguidewire22 is sufficiently rigid, in part due to theguidewire support tube19, so as to be advanced by theguidewire lever24 without buckling. Also, the guide surfaces34 and guidewire22 are configured to enable retraction of theguidewire22 back into theinsertion device housing12 when the finger pad28 (or other suitable mechanism in other embodiments) is slid proximally.

This distal sliding movement of theguidewire lever24 causes the distal end of theguidewire22 to extend distally from the open distal tip16B of theneedle16. Because of its anchored proximal end at theanchor point36 and its bent or looped U-shape configuration (FIG.1H), theguidewire22 is distally advanced at a linear rate of about twice the linear advancement rate offinger pad28, which results in about twice the length of guidewire extension when compared with the length of movement of theguidewire advancement slide28. This further desirably results in a relatively longer length of guidewire extension into the vein or other patient vessel so as to more suitably guide thecatheter42 into the patient's body. As such, the guidewire advancement assembly described here operates as a type of “reverse pulley” system for distal guidewire advancement. Note that other looping configurations of the guidewire can be included with thedevice10 in addition to those shown and described herein. Also, differing ratios of guidewire extension vs. advancement assembly movement are also possible in other embodiments.

Note that the above-described structures for providing a looping guidewire are only examples of structures that can suitably perform the desired functionality described herein. Indeed, other structures can be employed to accomplish the principles described in connection with the present embodiment. Also, though shown and described above to be attached to the catheter insertion device housing, the proximal end of the guidewire can be attached to other structures within/on the device, such as theneedle hub14, for instance. The majority length of the guidewire in one embodiment includes a metal alloy of nickel and titanium commonly referred to as nitinol, which is sufficiently rigid and can be disposed in the U-shaped configuration without retaining a memory of that position when the guidewire is advanced. Note that other suitable guidewire materials can also be employed.

Theinsertion tool10 further includes acatheter advancement assembly40 for selectively advancing in a distal direction thecatheter42, pre-disposed on theneedle16 external to thehousing12. In particular, thecatheter advancement assembly40 includes anadvancement member48 that initially resides within thecavity70 defined by thehousing12 and is used in selectively advancing thecatheter42 in a distal direction during use of theinsertion tool10 to insert the catheter into the body of the patient. As will be seen, theadvancement member48 also acts as a needle safety component for shielding theneedle16 from the user after use of thedevice10 is complete, as will be described further below.

FIGS.2A-2C depict further details of theadvancement member48 of thecatheter advancement assembly40 according to the present embodiment. As shown, theadvancement member48 defines an elongate body that is configured to straddle theneedle16 when theadvancement member48 is initially disposed within thehousing cavity70. The body of theadvancement member48 includes adistal portion49. A pair ofhub engagement tabs50 extend distally from the distal end of thedistal portion49, and each engagement tab includes aradially extending protuberance52. When theadvancement member48 is disposed within thehousing12, theneedle16 passes distally between theengagement tabs50, as seen inFIG.1H. Theadvancement member48 is configured such that theneedle16 extends the engagement tabs50 a relatively small distance radially outward while the needle is disposed therebetween. Thecatheter42, when disposed over theneedle16, as seen inFIG.1H, is kept in place against the open housingdistal end12D via theprotuberances52 of theengagement tabs50 producing a friction fit against an inner surface of thecatheter hub46. As will be seen further below, when theneedle16 is no longer disposed between theengagement tabs50, the tabs withdraw radially inward, allowing the catheter to separate from the distal end of theadvancement member48.

Thedistal portion49 of theadvancement member48 further includes anadvancement tab54 for assisting with manual distal extension of the advancement tab during deployment of thecatheter42, and a plurality of top andbottom ribs56 that extend across the advancement member body to join twoelongate arms58 that longitudinally extend proximally from the distal portion.FIGS.1G and1H show that thearms58 straddle theneedle16 when theadvancement member48 is initially disposed in thecavity70 of thehousing12. The top andbottom ribs56 are positioned such that the distal tip16B of theneedle16 is shielded from user contact after extension of theadvancement member48 from thehousing12 is complete, as discussed further below. In addition, aproximal end56A of the ribs56 (FIG.1H) acts as a stop against a pair oflock wedges72, formed in thehousing12, to prevent further proximal entry of theadvancement member48 into thehousing cavity70.

Each of thearms58 includessecondary tabs60 disposed proximal to thedistal portion49 to assist, together with theadvancement tab54, in manually extending theadvancement member48 in the distal direction by enabling locations for a finger of the user to push against. Proximate the proximal end of eachadvancement member arm58, alocking tab62 is included. The lockingtabs62 are deformable to enable them to pass over thelock wedges72 when theadvancement member48 is distally extended during catheter distal advancement (described below) so as to prevent re-entry of the advancement member into thehousing cavity70, which also ensures that the distal tip16B of theneedle16 remains shielded by theribs56 of the advancement memberdistal portion49. In addition, stop surfaces64 are included on theadvancement member arms58 proximal to each lockingtab62 so as to prevent theadvancement member48 from completely separating from thehousing12 when the advancement member is distally extended from the housing. This is accomplished by eachstop surface64 engaging with a respective one of thelock wedges72, which prevents further distal movement of the advancement member. Thus, after full distal extension, theadvancement member48 is locked from either proximal movement to cause re-entry of the advancement member into thehousing cavity70 via engagement of the lockingtabs62 with thelock wedges72, or further distal movement via engagement of the stop surfaces64 with the lock wedges. In addition to these, other modes for preventing undesired proximal and distal movement of the advancement member after distal extension thereof can also be employed.

Note that in one embodiment the outer diameters of theneedle16 and thecatheter tube44 are lubricated with silicone or other suitable lubricant to enhance sliding of the catheter tube with respect to the needle and for aiding in the insertion of the catheter into the body of the patient.

FIGS.3A-3C depict various stages of use of theinsertion device10 in placing thecatheter42 in the vasculature of a patient. For clarity, the various stages are depicted without actual insertion into a patient being shown. With theinsertion tool10 in the configuration shown inFIG.1E, a user grasping theinsertion device10 first guides the distal portion of theneedle16 through the skin at a suitable insertion site and accesses a subcutaneous vessel.

After needle access to the vessel is confirmed, theguidewire advancement assembly20 is actuated, wherein the finger pad28 (disposed in theslot32 defined in the housing) is advanced by the finger of the user to distally advance the guidewire22 (FIG.3A), initially disposed within thehollow needle16. Note that theguidewire22 is distally advanced by theguidewire lever24, which is operably attached to theslidable finger pad28.

Distal advancement of theguidewire22 continues until thefinger pad28 has been distally slid a predetermined distance, resulting in a predetermined length of theguidewire22 extending past the distal end of theneedle16, as shown inFIG.3A.

At this point, thefinger pad28 is slid distally an additional distance, which causes the push tab30 (FIG.2B) of theguidewire lever24 to abut against theproximal end56A of theribs56 of theadvancement member48 of thecatheter advancement assembly40. This in turn causes theadvancement member48 to distally advance out the open distal end of thehousing12D a predetermined distance. As it is removably attached to thedistal portion49 of theadvancement member48 via thehub engagement tabs50, thecatheter42 is also distally advanced the predetermined distance. Distal advancement of theadvancement member48 ceases when the notch above the guidewirelever push tab30 contacts the distal end of the slot32 (FIG.1I) defined in thehousing12 and stops further distal sliding of thefinger pad28.

Once theguidewire lever24 has been fully distally extended via sliding of thefinger pad28, which in turn has extended theguidewire22 past the distal end16B of theneedle16 and into the vessel of the patient and has distally advanced theadvancement member48 and connected catheter42 a predetermined distance away from thedevice housing12, further manual distal advancement of theadvancement member48 is performed by a finger of the user via pushing against theadvancement tab54 and then thesecondary tabs60 of the advancement member, as seen inFIG.3B. This causes thecatheter tube44 to slide over distal portions of theneedle16 and guidewire22 and into the patient's vasculature via the insertion site. In light of this, it is appreciated that thefinger pad28 acts as a first member used to advance theguidewire22, whereas theadvancement tab54 acts as a second member used to advance thecatheter42, in the present embodiment. It is appreciated that thefinger pad28 is distally slidable to a distal termination point that is proximate a proximal commencement point of the second member such that movement of a finger of the user from thefinger pad28 to theadvancement tab54 occurs without substantial repositioning of the finger, in the present embodiment.

Theadvancement member48 and connectedcatheter42 are manually distally advanced until the advancement member has been fully extended, as seen inFIG.3B, i.e., the lockingtabs62 slide over and lock with thelock wedges72 defined by thehousing12, thus locking the advancement member from further distal advancement. In this fully extended state of theadvancement member48, thedistal portion49 is disposed over theneedle16 and shielded by theribs56. Thus, theadvancement member48 serves as one example of a needle safety component, according to the present embodiment. The engagement of the above-mentionedlocking tabs62, as well as the stop surfaces64, of theadvancement member48 with thelock wedges72 prevents further distal or proximal movement of the advancement member, thus desirably ensuring continued shielding of the distal end16B of theneedle16.

The above distal advancement of theadvancement member48 likewise distally advances thecatheter tube44 over theneedle16 and guidewire22 and into the vessel of the patient until thecatheter hub46 abuts the insertion site of the needle through the skin. As theneedle16 is no longer disposed between them, thehub engagement tabs50 compress radially inward, thus releasing the friction fit between theprotuberances52 and the interior surface of the catheter hub. This enables thecatheter42 to be separated from theadvancement member48, as shown inFIG.3C. Thecatheter42, now in place in the patient, can be prepared for use and dressed down, per standard procedures. Theninsertion device10 can be discarded.

In light of the above, it is appreciated that theguidewire advancement assembly20 and thecatheter advancement assembly40 operate in conjunction with one another in the present embodiment and thus comprise together a master advancement assembly for placing thecatheter42. It is further appreciated that the master advancement assembly can include both or only one of a guidewire advancement assembly and a catheter advancement assembly in other embodiments.

It is noted that thedevice10 is configured such that grasping of the device and advancement of theguidewire22 and thecatheter42 can be performed by only one hand of the user. This is accomplished in the present embodiment by placing the grip surfaces74 and thefinger pad28 in convenient locations for user grasping of thedevice10, together with enabling thefinger pad28 andguidewire advancement assembly20 to be used to advance theguidewire22 and the catheter42 a predetermined distance, followed by manual advancement of theadvancement member48 by a finger of the user. This can be performed by a single thumb, finger, or fingers of the user, in the present embodiment. Of course, other grasping and advancement configurations can be employed.

Reference is now made toFIG.4, which shows a continuousblood flash indicator80 that can be used with thedevice10 according to one embodiment. Theflash indicator80 is employed to indicate the presence of blood in the lumen of theneedle16 during use of thedevice10, thus assuring that proper access has been made by the needle into a vein or other desired blood-carrying vessel. As shown, theflash indicator80 includes atranslucent chamber82 that is generally cylindrical in shape, sealed at either end, and disposed about a portion of theneedle16 such that the needle protrudes out from either sealed end. In the present embodiment thechamber82 is disposed just distal to theneedle hub14 within thehousing12, though other locations along the needle are also possible.

Two notches—afirst notch83 and asecond notch84—are defined in theneedle16 so as to provide fluid communication between the lumen of the needle and the interior of thechamber82. Thenotches83 and84 replace the notch18 (FIG.1I) in one embodiment, and are included in addition to thenotch18, in another embodiment. It is appreciated that, in one embodiment, blood passage through thenotch18 serves as an initial indicator that the distal end16B of the needle has entered the vein, while the embodiment shown here serves as an additional indicator to verify that the needle distal end remains in the vein after initial access.

In the present embodiment, thesecond notch84 is disposed just proximal to the distal termination point of theguidewire support tube19, though other locations for the notches are possible. Also as shown, theguidewire22 passes through the lumen of theneedle16 so as to extend through theflash indicator80. Thefirst notch83 is disposed distal to thesecond notch84 toward the distal end of thechamber82, as shown inFIG.4.

When vessel access is achieved by the distal end16B of theneedle16, blood travels proximally up the lumen of the needle, between the inner surface of the needle and the outer surface of theguidewire22, disposed in the needle lumen. Upon reaching the relatively more distalfirst notch83 defined in theneedle16, a portion of the blood will pass through the first notch and enter thechamber82. As the blood fills thechamber82, a user can observe the translucent chamber through thetranslucent housing12 of theinsertion device10 and view the blood therein, thus confirming that the vessel access has been achieved. In another embodiment, thehousing12 can be configured such that direct viewing of thechamber82 is possible, e.g., with no intervening structure interposed between the chamber and the user.

Thesecond notch84 is employed to provide an exit point for air in thechamber82 to equalize air pressure and enable the blood to continue entering the chamber via thefirst notch83. It is noted that the spacing between the inner surface of theneedle16 and the outer surface of theguidewire support tube19 is such that air but not blood can pass therebetween, thus enabling air pressure equalization in thechamber82 without blood passage through thesecond notch84. In this way, theflash indicator80 is a continuous indicator, enabling a continuous flow of blood into thechamber82 while the needle distal end16B is disposed within the vessel.

Note that thechamber82 of theflash indicator80 of the present embodiment is disposed so as to be directly under theribs56 of thedistal portion49 of the as-yetun-advanced advancement member48 during the establishment of needle access to the vessel. This enables theribs56 to act as an indicia, or an approximate blood flash meter, as the blood proceeds proximally within thechamber82 of theflash indicator80; a user observing the blood in the spaces between theribs56 proceeding proximally can view the proximal travel of the blood during the catheter placement procedure. In another embodiment, a spring disposed in thehousing12, such as for retraction of theneedle16, can also serve as indicia to meter the flow of blood in the flash indicator. These and other indicia for metering blood flow in the flash indicator are therefore contemplated.

Note that thecatheter insertion device10 can include more than one flash indicator. In one embodiment and as mentioned above, for instance, theblood flash indicator80 can be included, along with another flash indicator, such as thenotch18, which enables blood present in thelumen17 of theneedle16 to proceed proximally up the space between the outer surface of the needle and the inner surface of thecatheter42.

FIGS.5 and6 show another example of a continuousblood flash indicator80 according to one embodiment, wherein anabsorbent component86 capable of absorbing blood or other desired body fluid is wrapped/disposed about a portion of the outer surface of theneedle16 so as to cover thenotch18 of the needle (FIGS.1I,1J). Cotton, gauze, fabrics, wood-based products, hydrophilic materials, mesh materials, polymeric materials, polyester, woven materials, and other suitable substances—both natural and synthetic materials—are examples of materials that can be employed for the absorbent component. In one embodiment, the absorbent material is woven to include a weave such that the blood fills the spaces between the woven material. This enables the amount of expansion of the absorbent material as well as the speed of blood travel through the absorbent material. Note that expansion of the absorbent material can be radial, longitudinal, a combination of both, etc.

The absorbent component preferably has a color different from red so as to indicate when blood has been absorbed. Atranslucent cover88, including a thermoplastic or other suitable material, can be optionally placed over theabsorbent component86 in one embodiment to contain it and isolate blood absorbed thereby.

When vessel access is achieved by the distal end16B of theneedle16, blood travels proximally up the lumen of the needle, between the inner surface of the needle and the outer surface of theguidewire22, which is disposed in the needle lumen. Upon reaching thenotch18 defined in theneedle16, a portion of the blood will pass through the notch and be absorbed by theabsorbent component86, which changes colors due to the blood absorption. This indicates to the user that the needle distal tip16B is properly located in the vessel. As the needle distal tip16B remains in the vessel, blood will continue to be absorbed by theabsorbent component86, causing the absorbed blood to progress along the length of the absorbent component, thus providing a continuous blood flash indication.FIG.7 shows that the diameter of theabsorbent component86 can vary in size; as such, modifications to what has been shown and described herein are therefore contemplated. In another embodiment it is appreciated that the absorbent material can expand in size as it absorbs blood or other fluid with which it is to be used.

FIGS.30A and30B depict various details of a variation of theblood flash indicator80 ofFIGS.5 and6 wherein theabsorbent component86 includes a strip of absorbent material a first portion of which is disposed over a notch in theneedle16, such as thefirst needle notch83. The first portion of the absorbent material strip is connected to a second portion of the absorbent material strip that longitudinally extends proximally from thefirst notch83, though it may also extend in other directions and possess other shapes, sizes, etc. The second portion of the absorbent material strip is secured to aninner surface70A of thehousing cavity70 and is connected to the first portion covering thefirst notch83 via atether180, which also may comprise a portion of the absorbent material. So configured, theabsorbent component86 absorbs blood (or other fluid) that exits thelumen17 of theneedle16 via thefirst notch83, such as when the distal end16B of the needle is disposed within a vein of the patient. As it continues to exit thefirst notch83, the blood will be continually absorbed by theabsorbent component86 and travel from the first portion of the absorbent material, across thetether180, and proximally along the strip of absorbent material, thus providing a continuous flash indicator to the observing user. Thetether180 is frangible in the one embodiment to enable theneedle16 to be retracted into thehousing12. Upon retracting theneedle16, thetether180 will break, allowing the second portion of the absorbent material that is affixed to the housing cavityinner surface70A to remain in place. In one embodiment, theflash indicator80 described herein in connection withFIGS.30A and30B can be included in a flash chamber, such as theflash chamber82 shown inFIG.4, for instance. A variety of materials may be employed for the absorbent component, including those described in connection withFIGS.5-7.

FIGS.8A-8H depict details of thecatheter insertion device10 according to another embodiment, including thehousing12 from which distally extends theneedle16 secured in place by theneedle hub14 within the housing. Thecatheter42 is removably disposed over theneedle16 such that the needle passes through thehub46 andcatheter tube44, as shown. Theguidewire22 is initially disposed within the housing and the lumen of theneedle16 and is selectively advanceable.

Theinsertion device10 includes anadvancement assembly120 for selectively advancing theguidewire22 and thecatheter42. Theadvancement assembly120 includes thefinger pad28 that is slidably connected with thehousing12. Thefinger pad28 is part of atelescoping portion90 and can be slid distally, as shown inFIGS.8E and8F, to distally advance theguidewire22 out the distal end16B of theneedle16. Once theguidewire22 has been fully deployed distally, further distal sliding of thefinger pad28 causes a portion of thetelescoping portion90 to engage the catheter hub46 (FIG.8G) and move thecatheter42 distally until the telescoping portion is fully extended (FIG.8H). At this point, thecatheter42 can be removed from theinsertion device10, at which point the telescopingportion90 has extended sufficient to cover and shield the distal tip16B of theneedle16, thus protecting the user from an unintended needle stick. Operation of theinsertion device10 ofFIGS.8A-8H as described herein enables the insertion device to be used in gaining access to a vessel in the body of a patient, deploying the guidewire and catheter into the vessel, and shielding theneedle16 after use, according to one embodiment. It is noted that the embodiment shown inFIGS.8A-8H shows one example of an insertion device that enables full guidewire and catheter advancement using a single finger pad and telescoping component.

FIGS.9A-9G depict details of aneedle safety component100 for use with a needle-bearing device, such as the insertion devices discussed herein. As shown, theneedle safety component100 is operably attached to theneedle16 and is disposed within a housing101 (FIGS.9E-9G). The needle safety component includes alocking element102 that is implemented here as a flattened, elongate metal bar in which a wave-shapedspring element104 is formed proximate one end and ahook portion108, which acts as a cam follower, on an opposite end. A D-shapedhole106 is defined through a central portion of thelocking element102 and theneedle16 initially passes through the hole and through thecatheter42, as shown inFIGS.9A and9B. Other hole shapes are also possible.

Acam110 is rotatably within thehousing101, as shown inFIG.9E, and includes ahub engagement portion112, a biasingportion114, and a lockingportion116. Before actuation, theneedle safety component100 is configured as shown inFIG.9E, with the needle safety component disposed over theneedle16 such that the needle passes through thehole106 and thecam110 rotated such that thehub engagement portion112 thereof engages a threaded portion of thehub46 of thecatheter42 so as to maintain engagement between the catheter and the needle safety component. The biasingportion114 of thecam110 also engages a portion of thecatheter hub46 to help maintain engagement between the hub and the cam. Note that thespring element104 is compressed against an interior surface of thehousing101 and thehook portion108 of thelocking element102 is disposed in the lockingportion116 of thecam110.

Once thecatheter42 has been positioned in the patient, theneedle16 is withdrawn from the catheter and retracted from thehole106 in thelocking element102, while thecatheter hub46 separates from engagement with thecam110, causing the cam to rotate counterclockwise. This rotation of thecam110 causes thehook portion108 of thelocking element102 to exit the lockingportion116 of thecam110 and slide up against the side of the cam, as seen inFIG.9F. This enables thespring element104 to un-compress from its compressed state (shown inFIG.9E), thus moving thehole106 out of alignment with the needle16 (FIG.9G) and desirably preventing the ability of the needle to re-emerge from thehousing101. The distal tip16B of theneedle16 is thus shielded from the user.

FIGS.10-12 depict various examples of configurations of theguidewire22 to enable blood to more easily pass through alumen17 of theneedle16, according to example embodiments. In the cross-sectional view ofFIG.10, for example, theguidewire22 is shown disposed in alumen17 of theneedle16. Theguidewire22 defines a flattened bar, or generally rounded rectangular, cross-sectional shape, which frees up space within theneedle lumen17 for the passage of blood therethrough, such as when the distal tip16B of theneedle16 enters a vein or other blood-carrying vessel of the patient. This, in turn, helps blood to flow into a blood flash indicator, such as those shown and described herein.

FIG.11 shows a cross-sectional configuration of theguidewire22 according to another embodiment, wherein the cross-sectional view of the guidewire depicts twolongitudinal notches117 defined in the guidewire profile.FIG.12 shows threenotches117 defined in the cross-sectional profile of theguidewire22. These and other guidewire configurations are therefore contemplated.

FIGS.13-17 depict various examples of configurations of a distal end22B of theguidewire22 that are designed to provide an atraumatic tip to prevent damage to the vessel during catheter insertion procedures. For example,FIG.13 shows theguidewire22 extending out the distal tip16B of theneedle16. The distal portion of theguidewire22 includes a curled configuration proximate the distal guidewire end22B.FIG.14 shows a J-tipped guidewire configuration wherein the guidewire distal end22B is doubled back on itself to form a J-tip. InFIG.15, a thermoplastic ormetallic ball122 is secured to the distal end22B of theguidewire22. InFIG.16, a three-dimensional whisk-like tip126 is provided at the distal end22B of theguidewire22.FIG.17 shows another configuration, wherein the guidewire distal end22B includes a ball attached thereto, and the distal portion of theguidewire22 is in a curled configuration. These and other modifications to theguidewire22 are therefore contemplated. Note that in one embodiment, theguidewire22 is composed of nitinol or other suitable material, as may be contemplated.

FIG.18 depicts the advancement member of thecatheter insertion device10 according to another embodiment, wherein the advancement member includes outwardly-extendingwings130 on a proximal end thereof, which are configured to prevent re-entry of the advancement member into the housing of the insertion device after full extension of the advancement member has been performed. This is but one example of modes by which unintended advancement member re-entry can be prevented.

FIG.18 further depicts a continuousblood flash indicator80 according to one embodiment, wherein anelongate channel134 is defined on a surface portion of theadvancement member48 so as to be in fluid communication with the lumen of theneedle16 of theinsertion device10. Thechannel134 is shaped as to define apathway136, such as a tortuous pathway for instance, along which blood present in the lumen of theneedle16 can travel after exiting the needle. Thepathway136 shown inFIG.18 defines a back-and-forth pattern along a top portion of a cylindrical segment of theadvancement member48, though a variety of different pathway designs can be employed. A user can observe the blood within thepathway136 defined by thechannel134 to confirm that the distal tip of theneedle16 is disposed in the vein or other desired blood-carrying vessel of the patient. As thepathway136 is relatively lengthy, the progress of the blood as it proceeds in the channel enables theflash indicator80 to function as a continuous flash indicator. It is appreciated that the channel and pathway can be formed with one of a variety of processes, including molding, machining, etc.

In light of the above,FIG.19 depicts the continuousblood flash indicator80 according to another embodiment, wherein thechannel134 defines a wavy, back-and-forth pathway136 on a surface of the advancement member. As before a distal end of thechannel134 is in fluid communication with the lumen of the needle of the insertion device (or other medical device) so that blood may exit the needle lumen and enter thepathway136 defined by the channel. Though shown here as being defined on theadvancement member48 of the catheter insertion device, thechannel134 can be included on other structures, including the hub or other portion of the catheter, the housing of the catheter insertion device/medical device/component, a valve assembly, etc. Further, though shown here as defined on a surface of the advancement member, the channel in other embodiments can include at least a portion of a tunnel or pathway defined below the surface of the advancement member/medical device/component. The pathway can be covered by a translucent or other cover, in another embodiment.

FIG.20 depicts the continuousblood flash indicator80 according to another embodiment, wherein thechannel134 defines a trunk-and-branch pathway136. InFIGS.21 and22, theadvancement member48 includes thechannel134 defining a back-and-forth pathway136 on a relatively thin distal portion (FIG.21) and a relatively thick portion (FIG.22) of the advancement member.FIG.23 depicts thechannel134 as defining a tooth-like pathway136 about a circumference of a distal portion of theadvancement member48, whileFIG.24 shows the channel defining an angled zig-zag pattern thereon. And inFIG.25, thechannel134 defines a converging back-and-forth pathway. Thus, these and other pathway designs, including circular, helix, etc., are contemplated.

It is appreciated that various other configurations are contemplated for the continuousblood flash indicator80 and its shaped pathway. For instance, the flash indicator can be included on/with thecatheter hub46 such that blood travels through thelumen17 of theneedle16 to the catheter hub and into the flash indicator. In yet another embodiment, theflash indicator80 is included as a removable piece temporarily attached to thecatheter hub46 or other component of theinsertion device10. It is further appreciated that the flash indicators described herein can also be used to indicate the presence of other fluids in the needle, including other bodily fluids, for instance. These and other modifications are contemplated.

FIGS.26A-26D depict details of thecatheter insertion device10 according to another embodiment, wherein thehousing12 has been removed from the views inFIGS.26A-26C for clarity. Theinsertion device10 here includes theneedle16 distally extending from thehousing12, with thecatheter42 removably disposed over the needle such that the needle passes through thehub46 andcatheter tube44. Theguidewire22 is initially disposed within the housing and the lumen of theneedle16, and is selectively advanceable.

Theinsertion device10 includes theadvancement assembly120 for selectively advancing theguidewire22 and thecatheter42. Theadvancement assembly120 includes anadvancement slide140, which in turn includes afinger pad148 that is slidably connected with thehousing12. Aguidewire carriage124 is also included, from which distally extends theguidewire22 to enter theneedle16. Anend piece158 is also included at the distal end of thehousing12 and serves to push thecatheter42 distally, as will be discussed.

The initial position of thecatheter insertion device10 is shown inFIG.26A (excluding the omittedhousing12, for clarity), wherein theadvancement slide140 and theguidewire carriage124 are coupled together, as shown inFIG.26C. In detail, anarm152 distally extending from theguidewire carriage124 couples with anangled tab150 of theadvancement slide140 via anotch154 defined by the arm. Note that thearm154 is downwardly biased, which would cause the arm to disengage thenotch154 from theangled tab150; however, thehousing12 is shaped in the position shown in26A to constrain the arm to maintain engagement with the angled tab.

The above configuration enables joint distal movement of theadvancement slide120 and theguidewire carriage124 when the uses manually engages thefinger pad148 and slides the advancement slide distally to the position shown inFIG.26B. This movement causes theguidewire22 to fully extend out the distal end16B of theneedle16, as with other embodiments. At this point, thenotch154 of the downwardly-biasedarm152 disengages with theangled tab150 due to thearm152 no longer being constrained by the housing12 (or other suitable structure) to maintain the engagement with the angled tab. Thus, further distal movement of theguidewire22 by theguidewire carriage124 is prevented. A locking mechanism can be included to lock theguidewire carriage124 in place, in one embodiment. Reversing the process by proximally sliding theadvancement slide120 causes theguidewire carriage124 to re-couple with the advancement slide via re-coupling of thenotch154 of thearm152 with theangled tab150.

Next, further distal sliding of theadvancement slide120 via thefinger pad148 causes the advancement slide to engage theend piece158, which in turn distally advances thecatheter42 off theneedle16 and into the patient, as desired. Once fully distally extended, theadvancement slide140 shields the distal tip16B of theneedle16, thus protecting the user. This embodiment thus shows an example of an insertion device that enables full guidewire and catheter advancement using a single advancement assembly.

FIGS.27A-27E depict details of thecatheter insertion device10 according to another embodiment, wherein a top portion of thehousing12 has been removed for clarity. Theinsertion device10 here includes theneedle16 distally extending from thehousing12, with thecatheter42 removably disposed over the needle such that the needle passes through thehub46 andcatheter tube44. Theguidewire22 is initially disposed within the housing and the lumen of theneedle16, and is selectively advanceable.

Theinsertion device10 includes theadvancement assembly120 for selectively advancing theguidewire22 and thecatheter42. Theadvancement assembly120 includes a guidewire lever, which in turn includes thefinger pad148 that is slidable along a portion of the length of theinsertion device housing12. Twogrips162 are disposed proximate the distal end of theinsertion device10 to assist with user grasping of the insertion device.

Theinsertion device10 further includes acatheter slide168 that is distally slidable within thehousing12 to distally advance thecatheter42 during use of the insertion device for catheter insertion procedures. Thecatheter slide168 includes a pair ofwings166 that interact with theguidewire lever144 to enable catheter advancement after theguidewire22 has been fully advanced.

The initial position of thecatheter insertion device10 is shown inFIG.27A (excluding the omitted top housing portion of thehousing12, for clarity), wherein theguidewire lever144 and itsfinger pad148 have not yet been distally advanced. Distal sliding of thefinger pad148 manually by the user causes theguidewire lever144 to distally advance theguidewire22 out the distal end16B of theneedle16, as with other embodiments. Once theguidewire22 has been fully extended, a thinnedportion164 of theguidewire lever144 is now positioned adjacent thewings166 of thecatheter slide168, as seen inFIG.27B. So positioned, the thinnedportion164 of theguidewire lever144 enables thewings166—which until this point were forced radially outward by the guidewire lever (FIG.27C)—to contract radially inward (FIG.27D) so as to enable thecatheter slide168 to be distally advanced by further distal sliding movement by thefinger pad148 of the guidewire lever, as seen inFIG.27E. This distal advancement of thecatheter slide168 causes thecatheter42 to be distally advanced off theneedle16 and into the patient, as desired. This embodiment thus shows another example of an insertion device that enables full guidewire and catheter advancement using a single advancement assembly.

FIG.28 depicts the continuousblood flash indicator80 of thecatheter insertion device10 shown inFIGS.27A-27E, including thechannel134 defining thepathway136 implemented as a spiral disposed within thehousing12 about a distal portion of theadvancement assembly120.

FIG.29 depicts details of thecatheter insertion device10 according to another embodiment, including separately deployable assemblies, i.e., theguidewire advancement assembly20 including theguidewire lever24, and thecatheter advancement assembly40 including atab172 and a plurality oftelescoping segments170. During use of theinsertion device10, theguidewire22 is distally extended manually via theguidewire lever24, after which thecatheter42 is distally extended manually via thecatheter advancement assembly40 and the includedtab172. Thetelescoping segments170 maintain attachment of thecatheter advancement assembly40 with thehousing12 and also help shield the needle from unintended user contact. Note that, though two are shown here, one, three ormore telescoping segments170 can be employed. This embodiment thus shows an example of an insertion device that enables full guidewire and catheter advancement using a separate advancement assembly for the guidewire and the catheter.

It is noted generally that, in one embodiment, the advancement assembly/assemblies can be configured to prevent distal advancement of the catheter until full distal advancement of the guidewire has been achieved. In other embodiments, a single advancement assembly is employed to advance both the guidewire and the catheter. For instance, the finger pad of an advancement assembly can be moved a first distance to distally advance the guidewire, after which further guidewire advancement is automatically or otherwise disengaged/prevented and the catheter distal advancement is commenced as the finger pad is moved a second distance, as inFIGS.26A-26D. In another embodiment, a single finger pad is moved a first distance to distally advance the guidewire, then moved a second distance to continue moving the guidewire distally while also now moving the catheter distally as well, such as inFIGS.27A-27E. These and other possible configurations are contemplated.

Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the embodiments is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (19)

What is claimed is:

1. A needle assembly, comprising:

a needle defining a needle lumen extending from a distal tip to a proximal section;

a flash chamber sealed about the proximal section of the needle, the flash chamber configured as a blood flash indicator observable by a user of the needle assembly;

a first notch defined in a side wall of the needle within the flash chamber to enable blood to pass from the needle lumen when the distal tip of the needle is disposed in a blood-carrying vessel of a patient; and

a second notch defined in the side wall of the needle within the flash chamber proximal of the first notch, the second notch providing air pressure equalization within the flash chamber.

2. The needle assembly as defined inclaim 1, wherein the second notch is disposed proximal to the first notch.

3. The needle assembly as defined inclaim 1, wherein the flash chamber continuously fills with blood while the distal tip of the needle is disposed in the blood-carrying vessel of the patient.

4. The needle assembly as defined inclaim 1, wherein a guidewire is disposed within the needle lumen, the blood passing between the guidewire and an interior wall of the needle.

5. The needle assembly as defined inclaim 1, wherein indicia are placed in proximity to the flash chamber and are configured to meter a quantity of blood within the flash chamber.

6. A needle assembly, comprising:

a needle defining a needle lumen;

a notch defined in a side wall of the needle to enable blood to pass therethrough from the needle lumen when an open distal tip of the needle is disposed in a blood-carrying vessel of a patient; and

a flash indicator configured to indicate a presence of blood within the needle lumen, the flash indicator including an absorbent material disposed about the needle such that the absorbent material is disposed over and covers the notch, the absorbent material configured to absorb blood that passes from the needle lumen via the notch such that the absorbed blood is observable by a user of the needle assembly.

7. The needle assembly as defined inclaim 6, wherein the absorbent material is configured such that blood continuously moves along the absorbent material while the open distal tip of the needle is disposed in the blood-carrying vessel of the patient.

8. The needle assembly as defined inclaim 6, wherein the absorbent material is generally cylindrically shaped and includes at least one of a natural material and a synthetic material.

9. The needle assembly as defined inclaim 6, wherein the absorbent material extends proximally from the notch along an outer surface of the needle.

10. The needle assembly as defined inclaim 6, wherein the absorbent material includes cotton and is covered by a cover.

11. The needle assembly as defined inclaim 10, wherein the cover includes a polymeric material.

12. The needle assembly as defined inclaim 6, wherein the absorbent material is configured to expand in at least one of radial direction and a longitudinal direction upon absorption of a fluid.

13. The needle assembly as defined inclaim 6, wherein indicia are placed in proximity to the absorbent material and are configured to meter a quantity of blood absorbed by the absorbent material.

14. A needle assembly, comprising:

a needle defining a needle lumen, the needle disposed within a catheter to assist with insertion of the catheter into a blood vessel; and

an advancement member disposed over a proximal end of the needle, the advancement member configured to move the catheter over the needle into the blood vessel, the advancement member having an elongate channel defining a tortuous pathway on a surface portion thereof, the elongate channel in fluid communication with the needle lumen to indicate when the needle has entered the blood vessel.

15. The needle assembly as defined inclaim 14, wherein the needle assembly is included in a catheter insertion device.

16. The needle assembly as defined inclaim 14, wherein indicia are placed in proximity to the tortuous pathway and are configured to meter a quantity of blood disposed in the tortuous pathway.

17. The needle assembly as defined inclaim 14, wherein the tortuous pathway includes one of a helix, a spiral, a back-and-forth, a zig-zag, a trunk-and-branch, and a circular shape configuration.

18. The needle assembly as defined inclaim 14, wherein the elongate channel is in fluid communication with the proximal end of the needle.

19. The needle assembly as defined inclaim 1, wherein the first notch and the second notch are horizontally aligned at spaced apart locations in the side wall of the needle.

Images